Systems and methods of using a braided implant

ABSTRACT

A method of treating an aneurysm, including determining a diameter associated with a vessel having the aneurysm; selecting one of a plurality of braided implants for treating the vessel, wherein each braided implant comprises a porosity substantially consistent over up to a 1 mm diameter range, each braided implant configured to provide consistent porosity over different diameter ranges; and treating the vessel with the one of the plurality of braided implants.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application and U.S. patent application Ser. No. 16/153,517,now U.S. Pat. No. 10,463,510, are both a divisional application of U.S.patent application Ser. No. 16/056,135, now U.S. Pat. No. 10,456,280,filed Aug. 6, 2018. The entire contents of which are hereby incorporatedby reference.

FIELD

The present disclosure relates to implants within body vessels and moreparticularly to flow diverters, stents and related methods that includedbraided implants formed of strands of material.

BACKGROUND

Vascular disorders and defects such as aneurysms and otherarterio-venous malformations are especially difficult to treat whenlocated near critical tissues or where ready access to a malformation isnot available. Both difficulty factors apply especially to cranialaneurysms. Due to the sensitive brain tissue surrounding cranial bloodvessels and the restricted access, it is very challenging and oftenrisky to surgically treat defects of the cranial vasculature.

Typically, a stent-like vascular reconstruction device is first guidedbeneath the aneurysm to be treated using a delivery catheter. Onecommercially available reconstruction product is the CERENOVOUSENTERPRISE® Vascular Reconstruction Device and System as described,whereby The CERENOVOUS ENTERPRISE® stent device is carried by a centraldelivery wire and initially held in place on the delivery wire in acollapsed state by a sheath-type introducer. Typically, a deliverycatheter such as a PROWLER® SELECT® Plus microcatheter, alsocommercially available from Cerenovous and as disclosed by Gore et al.in U.S. Pat. No. 5,662,622, for example, is first positionedintravascularly with its distal tip slightly beyond the neck of theaneurysm. The tapered distal tip of the introducer is mated with theproximal hub of the delivery catheter, and the delivery wire is thenadvanced through the delivery catheter.

The CERENOVOUS ENTERPRISE® stent device has a highly flexible,self-expanding closed cell design with a number of coils of radiopaquewire to serve as markers at each flared end of the device. Manufactureof such markers is relatively time-consuming and expensive due to thesmall size of the stent and the need to wrap the radiopaque wiremultiple times around struts on the stent, which is especially difficultwithin closed cells of the stent.

Vascular aneurysms have several methods of treatment available. Oneapproach includes flow diverting stents that can be intra-vascularstents dense enough so that blood flow is diverted from entering theaneurysm. Such flow diverters are a recent and growing treatment option.Otherwise, the majority of the current generation of flow diverters arecomposed of a tubular braid of metal wires that are operate similar to afinger trap toy. These tubular braids are then compressed radially,delivered through a small-bore catheter to the treatment site, and thenexpanded in place.

Further, the weakness and non-linear nature of the neurovasculaturelimits the applicability of such stents in procedures, for example, inrepairing neurovascular defects. Furthermore, known delivery methods areless useful in vasoocclusive surgery, particularly when tiny vessels,such as those found in the brain, are to be treated. Accordingly, thereis a need for braided implants that can be used with delivery techniquesin vasoocclusive treatment of neurovascular defects that providesselective reinforcement in the vicinity of the neurovascular defect.There is also a need for a braided stent that reduces trauma or risk ofrupture to the blood vessel. The solution of this disclosure resolvesthese and other issues of the art.

SUMMARY

Disclosed herein are various exemplary devices, systems, and methods ofthe present disclosure that can address the above needs.

An object of the present solution is to provide one or more braidedimplants that are configured as flow diverters that provide longervessel diameter ranges for tapering vessels and maintain the targetporosity over a predetermined length (e.g., a 1 mm vessel diameterrange).

An object of the present solution is to increase the applicable vesseldiameter range for braided implants to minimize the number of devicesnecessary for practitioners when treating an aneurysm. In one example,the one or more braided implants comprise a broad plateau area of thecharacteristic porosity curve, indicating the braided implant(s) forvessel diameters within the plateau (resulting in a 1.0 mm wideindicated range), and overlapping the device indicated ranges so thedoctor has options for the best choice depending on the anatomypresented.

In certain examples, a braided implant is disclosed that is configuredas a flow diverter for treating an aneurysm. The implant can include abraided mesh configured to maintain a substantially consistent targetporosity in a tapered vessel over at least a 1 mm vessel diameter range.The braided mesh can also be configured to maintain the substantiallyconsistent target porosity between proximal and distal ends of thebraided mesh while in the tapered vessel.

In certain examples, the tapered vessel includes a proximal end diameterand a distal end diameter that differ by up to 1 mm, wherein the up to 1mm vessel diameter range is defined by comparing the proximal and distalend diameters. However, it is contemplated that the diameter can differby at least 0.5 mm or any other diameter differential as needed orrequired.

In certain examples, the substantially consistent target porosity isapproximately 70%.

In certain examples, the predetermined length between proximal anddistal ends of the braided mesh in the tapered vessel is at least 3 cm.

In certain examples, the predetermined length between proximal anddistal ends of the braided mesh in the tapered vessel is at least 2 cm.

In certain examples, the predetermined length between proximal anddistal ends of the braided mesh in the tapered vessel is at least 1 cm.

In certain examples, the predetermined length between proximal anddistal ends of the braided mesh in the tapered vessel is defined betweenthe proximal cavernous internal carotid artery and the internal carotidartery terminus.

In certain examples, a braided implant is disclosed for medical use. Theimplant can include a mesh having a proximal end and a distal end,wherein the mesh comprises a porosity substantially consistent betweenthe proximal and distal ends over a 1 mm radial range in vesseldiameter.

In certain examples, the porosity is approximately 70% over the 1 mmradial range in vessel diameter.

In certain examples, the braided implant further comprises an indicatedvessel diameter, and wherein the braided implant is configured such thatthe indicated vessel diameter coincides with a peak of a porosity curveof the braided implant. The braided implant can include a porosityplateau that corresponds to the 1 mm radial range in vessel diameterthat is disposed about the peak of the porosity curve.

In certain examples, across a vessel diameter range of 2 to 3 mm, aporosity of the braided implant ranges between 65% and 70%.

In certain examples, across a vessel diameter range of 2.5 to 3.5 mm, aporosity of the braided implant ranges between 65% and 70%.

In certain examples, across a vessel diameter range of 3.0 to 4.0 mm, aporosity of the braided implant ranges between 65% and 70%.

In certain examples, across a vessel diameter range of 3.5 to 4.5 mm, aporosity of the braided implant ranges between 65% and 70%.

In certain examples, across the braided implant is configured for avessel diameter range of 3.5 to 4.5 mm, and wherein the braided implantincludes a porosity of 69% at a vessel diameter of 3.5 mm; a porosity of69% at a vessel diameter of 4.0 mm; and a porosity of 67% at a vesseldiameter of 4.5 mm.

In certain examples, across a vessel diameter range of 4.5 to 5.5 mm, aporosity of the braided implant ranges between 65% and 70%.

In certain examples, a pore density of the braided implant is 18pores/mm².

In certain examples, a pore density of the braided implant is 23pores/mm².

In certain examples, a pore density of the braided implant is 19pores/mm².

In certain examples, a pore density of the braided implant isapproximately 18 to 23 pores/mm².

In certain examples, a target vessel treated by the braided implant istapered.

In certain examples, the braided implant is a substantially cylindricalporous structure.

In certain examples, the braided implant is a stent.

In certain examples, the braided implant is a flow diverter.

In certain examples, the braided implant is formed from a plurality ofsingle strands composed of at least a first material and one or moreradiopaque multi-strands.

In certain examples, the braided implant is woven to include at least asecond multi-strand.

In certain examples, the braided implant is formed from a plurality ofmulti-formed of monofilaments each laid together with monofilaments,respectively.

In certain examples, the braided implant further includes a pattern ofthat is woven, wherein the pattern comprises openings defined by aplurality of single strands oriented in a first direction and by aplurality of single strands oriented in a second direction transverse tothe first direction.

In certain examples, the braided implant further includes a pattern ofthat is braided, wherein the pattern comprises openings defined by aplurality of single strands oriented in a first direction and by aplurality of single strands oriented in a second direction transverse tothe first direction.

In certain examples, a system for treating an aneurysm is disclosed. Thesystem can include a plurality of braided implants, wherein each braidedimplant comprises a porosity substantially consistent over a different 1mm radial range in vessel diameter, each braided implant configured toprovide substantially consistent porosity over different 1 mm diameterranges.

In certain examples, the braided implant is configured for use in atapered vessel. The tapered vessel can include a proximal end diameterand a distal end diameter that differ by up to 1 mm. The different 1 mmradial range in vessel diameter can be defined by comparing the proximaland distal end diameters. However, the different 1 mm radial range invessel diameter can be also determined by measuring the vessel diameterat two separate locations at the treatment site.

In certain examples, the plurality of braided implants of the system isconfigured to treat any vessel within a 1.5 mm to 6 mm diameter range.

In certain examples, the plurality of braided implants of the systemincludes a first braided implant (10) configured to treat a vesseldiameter range of 2 to 3 mm; a second braided implant (10) configured totreat a vessel diameter range of 2.5 to 3.5 mm; a third braided implant(10) configured to treat a vessel diameter range of 3.0 to 4.0 mm; afourth braided implant (10) configured to treat a vessel diameter rangeof 3.5 to 4.5 mm; a fifth braided implant (10) configured to treat avessel diameter range of 4.0 to 5.0 mm; and a sixth braided implant (10)configured to treat a vessel diameter range of 4.5 to 5.5 mm. Theporosity of each braided implant (10) can range between 65% and 70% atthe indicated vessel range for the respective implant. In some examples,the porosity of each braided implant is approximately 70%. In someexamples, each braided implant further comprises an indicated vesseldiameter, and wherein the braided implant is configured such that theindicated vessel diameter coincides with a peak of a porosity curve ofthe braided implant. In some examples, each braided implant furtherincludes a porosity plateau that corresponds to the 1 mm range in vesseldiameter that is disposed about the peak of the porosity curve. In someexamples, each braided implant includes a pore density rangingapproximately between 18 to 23 pores/mm².

In some examples, a pore density of the first braided implant is 18pores/mm².

In some examples, a pore density of the second braided implant is 23pores/mm².

In some examples, a pore density of the third braided implant is 18pores/mm².

In some examples, a pore density of the fourth braided implant is 19pores/mm².

In some examples, a pore density of the fifth braided implant is 23pores/mm².

In some examples, a pore density of the sixth braided implant is 21pores/mm². In some examples, the braided implant includes radiopaquematerials such as platinum, chromium, cobalt, tantalum, tungsten, gold,silver, and alloys thereof.

In some examples, a system for treating an aneurysm is disclosed. Thesystem can include a plurality of braided implants, wherein each braidedimplant a porosity substantially consistent over a different 0.5 mmradial range in vessel diameter, each braided implant (10) configured toprovide substantially consistent porosity over different 0.5 mm radialdiameter ranges. However, other different radial ranges could be used asneeded or required with the system, including different vessel diameterranges of 0.3 mm, 0.4 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, or the like.

In some examples, a method is disclosed for treating an aneurysm. Themethod can include determining a vessel diameter associated with avessel of the aneurysm; selecting one of a plurality of braided implantsfor treating the vessel (e.g., based on the determined vessel diameter),wherein each braided implant includes a porosity substantiallyconsistent over at least a 1 mm vessel diameter range, each braidedimplant configured to provide substantially consistent porosity overdifferent 1 mm diameter ranges; and treating the vessel with the one ofthe plurality of braided implants.

In some examples, the vessel is tapered and includes a proximal enddiameter and a distal end diameter that differ by up to 1 mm, whereinthe determining the vessel diameter includes comparing the proximal anddistal end diameters or diameters.

In some examples, the vessel is tapered and has approximately 1 mmvessel diameter differential, the method further includes maintainingthe substantially consistent porosity across the approximately 1 mmvessel diameter differential.

In some examples, the method includes configuring each braided implantto cover a vessel diameter range with 0.5 mm overlap between eachrespective other braided implant.

In some examples, the vessel diameter is tapered and ranges betweenapproximately 3-4 mm.

In some examples, the vessel diameter is tapered and ranges betweenapproximately 3.5-4.5 mm.

In some examples, the vessel diameter is tapered and ranges betweenapproximately 4-5 mm.

In some examples, the vessel diameter is tapered and ranges betweenapproximately 4.5-5.5 mm.

In some examples, the vessel diameter is tapered and ranges betweenapproximately 5.0-6.0 mm.

In some examples, the vessel diameter is tapered and the plurality ofbraided implants is configured to treat vessel diameters ranging between1.5-6 mm.

In some examples, the determining a vessel diameter is implemented byX-ray, fluoroscopy, MRI, or other visualization means

In some examples, the treating the vessel includes advancing the braidedimplant to an aneurysm; and reconstructing blood flow in the vessel byexcluding the aneurysm and diverting blood flow from the aneurysm usingthe one of the plurality of braided implants.

To the accomplishment of the foregoing and related ends, certainillustrative aspects are described herein in connection with thefollowing description and the appended drawings. These aspects areindicative, however, of but a few of the various ways in which theprinciples of the claimed subject matter may be employed and the claimedsubject matter is intended to include all such aspects and theirequivalents. Other advantages and novel features may become apparentfrom the following detailed description when considered in conjunctionwith the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and further aspects of this solution are further discussedwith reference to the following description in conjunction with theaccompanying drawings, in which like numerals indicate like structuralelements and features in various figures. The drawings are notnecessarily to scale, emphasis instead being placed upon illustratingprinciples of the invention. The figures depict one or moreimplementations of the inventive devices, by way of example only, not byway of limitation.

FIG. 1 is a schematic enlarged view of a portion of an implant bodyformed of single strands and one or more radiopaque multi-strandsaccording to the present invention;

FIG. 2 depicts a side plan view of an example vessel contemplated foruse with the braided implant of this disclosure;

FIG. 3 is a graph that shows porosity versus vessel diameter for anexample braided implant of this disclosure;

FIG. 4 is a graph that compares the porosity versus vessel diameter foran example braided implant of this disclosure versus a conventionaldevice;

FIG. 5 is a graph that shows the pore density and number of wires versusvessel diameter for a set of example braided implants of thisdisclosure;

FIG. 6 is a graph that compares the porosity versus vessel diameter fora set of example braided implants of this disclosure versus a set ofconventional devices;

FIG. 7 depicts a flow diagram outlining example method steps of thisdisclosure; and

FIG. 8 depicts a flow diagram outlining example method steps of thisdisclosure.

DETAILED DESCRIPTION

Although example embodiments of the disclosed technology are explainedin detail herein, it is to be understood that other embodiments arecontemplated. Accordingly, it is not intended that the disclosedtechnology be limited in its scope to the details of construction andarrangement of components set forth in the following description orillustrated in the drawings. The disclosed technology is capable ofother embodiments and of being practiced or carried out in various ways.

It must also be noted that, as used in the specification and theappended claims, the singular forms “a,” “an” and “the” include pluralreferents unless the context clearly dictates otherwise. By “comprising”or “containing” or “including” it is meant that at least the namedcompound, element, particle, or method step is present in thecomposition or article or method, but does not exclude the presence ofother compounds, materials, particles, method steps, even if the othersuch compounds, material, particles, method steps have the same functionas what is named.

In describing example embodiments, terminology will be resorted to forthe sake of clarity. It is intended that each term contemplates itsbroadest meaning as understood by those skilled in the art and includesall technical equivalents that operate in a similar manner to accomplisha similar purpose. It is also to be understood that the mention of oneor more steps of a method does not preclude the presence of additionalmethod steps or intervening method steps between those steps expresslyidentified. Steps of a method may be performed in a different order thanthose described herein without departing from the scope of the disclosedtechnology. Similarly, it is also to be understood that the mention ofone or more components in a device or system does not preclude thepresence of additional components or intervening components betweenthose components expressly identified.

As discussed herein, vasculature of a “subject” or “patient” may bevasculature of a human or any animal. It should be appreciated that ananimal may be a variety of any applicable type, including, but notlimited thereto, mammal, veterinarian animal, livestock animal or pettype animal, etc. As an example, the animal may be a laboratory animalspecifically selected to have certain characteristics similar to a human(e.g., rat, dog, pig, monkey, or the like). It should be appreciatedthat the subject may be any applicable human patient, for example.

As discussed herein, “operator” may include a doctor, surgeon, or anyother individual or delivery instrumentation associated with delivery ofa braid body to the vasculature of a subject.

As discussed herein, “strand” is intended in its broadest meaning toinclude a wire, a fiber, a filament, or other single elongated member.

As discussed herein, “radiopaque” is utilized for its normal meaning ofbeing radiodense, that is, formed of one or more materials which inhibitthe passage of electromagnetic radiation to increase visibility duringimaging. Suitable radiopaque materials for use according to the presentinvention include platinum, chromium, cobalt, tantalum, tungsten, gold,silver, and alloys thereof.

The braided implants 10 of this disclosure can be better understood whenlooking at the figures appended to this disclosure. For instance, inFIG. 1, a schematic enlarged view of a portion of a braided implant 10is shown according to an example of this disclosure. Braided implant 10can be formed of single strands 12 composed of at least a first materialand one or more radiopaque multi-strands 14. In this construction,implant 10 is woven to include at least a second multi-strand 16. Inanother construction, indicated by dashed lines, the implant 10 furtherincludes multi-strands 18 and 20 formed of monofilaments 22 and 24 eachlaid together with monofilaments 26 and 28, respectively. The pattern ofimplant 10, which is woven in some constructions and braided in otherconstructions, includes openings 30 defined by single strands 12oriented in a first direction and by single strands 24 and 25 orientedin a second direction that is transverse to the first direction, forexample. Implant 10 further includes openings 32 and 34 defined oneither side of multi-strand 14 by single strands 13 and 15 oriented inthe same direction as multi-strand 14 and by single strands 24, 25 and27 oriented in a transverse direction. In some constructions, openings32 and 34 are slightly larger than openings 30 which are defined only bysingle strands; in other constructions, all openings 30, 32 and 34 aresubstantially the same.

Other embodiments are contemplated for implants 10 of this disclosureand can also be observed in U.S. Pat. Pub. 2016/0058524, a referencethat is incorporated in its entirety herein. Braided implant 10constructions of this disclosure in some examples are considered to havesubstantially the same pattern as if implant 10 were formed solely fromsingle strands of material. Since the multi-strands are braided, wovenor otherwise laid in parallel to each other in the same manner as ifsingle strands of radiopaque material were utilized, and especially wheneach filament of the multi-strand has the same diameter as the singlestrands, there is little or no mechanical impact to the performance ofthe implant, such as flexibility, ability to expand, and crimpedprofile.

Turning to FIG. 2, a side plan view of an example vessel is shown thatis contemplated for use with implant 10 of this disclosure. As can beseen, the example vessel tapers along its longitudinal axis of theinternal carotid artery (ICA). See, Rai A T, Hogg J P, Cline B, et al. JNeuroIntervent Surg (2012) which is incorporated by reference in itsentirety. The Rai study undertook to determine the typical length,diameter and taper of vessels in the anterior cerebral circulation. Thearterial diameter was measured at the proximal cavernous ICA, the ICAterminus, the middle cerebral artery MCA origin and an M2 origin. Thelength between these endpoints was calculated along the center line. Thevessel taper was calculated for the ICA as the change in caliber perunit length. In carrying out this study, the Rai study determined thatthe mean diameter at the cavernous ICA and the ICA terminus was 5±0.6 mmand 3.6±0.4 mm, respectively. The mean ICA taper was 0.04±0.02 mm/1 mm.For the MCA, the diameter at the MCA and M2 origins measured 3.1±0.4 mmand 2.4±0.4 mm, respectively.

FIG. 2 provides non-limiting examples of diameter measurements atrespective lengths taken from the proximal cavernous ICA towards the ICAterminus further exemplifying the tapering nature of the vessel. The Raistudy confirmed that the ICA tapers from its proximal cavernous segmentto the ICA terminus that implant 10 is configured to treat.

Turning to FIG. 3, a graph is provided that shows the percent porosityof an example braided implant 10 of this disclosure as compared tovessel diameter that were investigated for this disclosure. As can beseen, the braided implant 10 of this disclosure held a relativelyconsistent pore size and porosity over a 1 mm vessel diameter range.Throughout this disclosure, when referring to a vessel diameter range,it is intended that this term means a range of diameters as measuredbetween two separate locations in the vessel being treated by braidedimplant 10. For example, a practitioner using X-ray visualization couldmeasure the vessel diameter of the proximal cavernous ICA as 4.2 mmwhereas the vessel diameter towards the ICA terminus could be 3.2. Inthis respect, the vessel diameter range in this example tapered vesselwould be 1 mm. The implants 10 of this disclosure are designed toaccommodate such tapering vessels across these example vessel diameterranges while also maintaining a substantially consistent targetporosity. This is particularly advantageous since it means fewerimplants are required to accommodate vessels that tapering greater thanconventional devices (e.g., vessel diameter ranges of approximately 0.25mm) or tortuosity typically seen in the neurovasculature.

With this, FIG. 3 depicts an example vessel having a 1 mm vesseldiameter range between 3.5 mm to 4.5 mm. In this example, the braidedimplant 10 of this disclosure maintained approximately 70% porosity.Specifically, at a diameter of 3.5 mm, the porosity of the braid wasapproximately 69%. At a diameter of 4.0 mm, the porosity of the braidwas approximately 69%. At a diameter of 4.5 mm, the porosity of thebraid was approximately 67%.

Turning to FIG. 4, a graph is provided that summarizes a comparisoncarried out whereby the porosity versus vessel diameter is shown for anexample implant 10 of this disclosure versus the Pipeline™ EmbolizationDevice (PED) by Medtronic across a 1 mm vessel diameter range.Specifically, braided implant 10 and the PED device were comparedbetween a vessel diameter range of 3.5 mm to 4.5 mm. As can be seen, thebraided implant 10 of this disclosure held a relatively consistent poresize and porosity over a 1 mm vessel diameter range at about 70% acrossthe same range previously shown in FIG. 3. Conversely, the PED device at3.5 mm vessel diameter demonstrated 80% porosity, at 4 mm vesseldiameter demonstrated a 70% porosity, and at 4.5 mm vessel diameterdemonstrated less than 50% porosity. Stated differently, the porosity ofthe PED device diminished appreciably as the diameter of the vesselincreased across the 1 mm range, whereas the example braided implant 10of this disclosure demonstrated a substantially consistent porosity overthe 1 mm diameter range.

FIG. 4 also shows the porosity of each device as it changes whileexpanding and it is characteristically the same. In certain examples,the braided implant 10 is designed such that the indicated vesseldiameter coincides with the peak of the porosity curve and the plateauarea around it (which deviates from the target porosity very little).For example, in FIG. 3 the braided implant 10 shown is indicated for anartery diameter range from 3.5 mm to 4.5 mm. This device remains veryclose to the target porosity of 70% throughout its expansion range,which has a width of 1.0 mm.

When the device is compressed, for example, it is dense so its porosityis very low (see, e.g., the lower-left of FIG. 3). As the deviceexpands, the porosity increases since the pores of the braided implant10 are opening. At a certain point, the porosity reaches a peak, whichis when the braiding angle is at 90 degrees since each pore can be asquare, and as large as it can get, shown at the center arrow of FIG. 3.Further expansion of the diameter past this peak then reduces the sizeof each pore and thus the porosity. When the braided implant 10 reachesmaximum diameter at its expansion limit, then braided implant 10 isagain very dense and porosity is correspondingly low (see, e.g.,lower-right of FIG. 3).

In contrast, other devices known might be designed differently, so thatthe plateau area of the porosity curve is not as wide as 1.0 mm, or theymight be indicated for artery diameters that do not coincide with theplateau area. In these older approaches, the range of diameters thatcoincide with the target porosity would be narrow since outside theplateau, small changes in artery diameter result in large deviationsfrom the target porosity. Accordingly, other devices known would beincapable of being able to treat a wider range of vessel diameters.

Turning to FIG. 5, a graph is provided that summarizes the porosityversus vessel diameter for an example braided implant 10 of thisdisclosure. Specifically, FIG. 5 shows six separate braided implants(10) that each have approximately a 1 mm range in vessel diameter, andoffset from one another by approximately half of that range (0.5 mm).The legend shows the range of vessel diameters from minimum to maximumand corresponding label for the applicable braided implant (10). Forexample, a first braided implant (10) is configured for a vesseldiameter range between 2.0 mm and 3.0 mm with a label of 2.5 mm. Thefirst braided implant (10) has 48 wires with a pore density (mm²) of 18.A second braided implant (10) is configured for a vessel diameter rangebetween 2.5 mm and 3.5 mm with a label of 3 mm. The second braidedimplant (10) has 64 wires with a pore density (mm²) of 23. A thirdbraided implant (10) is configured for a vessel diameter range between3.0 mm and 4.0 mm with a label of 3.5 mm. The third braided implant (10)has 64 wires with a pore density (mm²) of 18. A fourth braided implant(10) is configured for a vessel diameter range between 3.5 mm and 4.5 mmwith a label of 4.0 mm. The fourth braided implant (10) has 72 wireswith a pore density (mm²) of 19. A fifth braided implant (10) isconfigured for a vessel diameter range between 4.0 mm and 5.0 mm with alabel of 4.5 mm. The fifth braided implant (10) has 96 wires with a poredensity (mm²) of 21. A sixth braided implant (10) is configured for avessel diameter range between 4.5 mm and 5.5 mm with a label of 5 mm.The sixth braided implant (10) has 96 wires with a pore density (mm²) of21.

Turning to FIG. 6, a graph is provided that summarizes a comparisoncarried out whereby the porosity versus vessel diameter is shown for setof example implants (10) of this disclosure versus a set of PED devicesacross different vessel diameter ranges, including from 2 mm to 6 mm.Specifically, in the first braided implant 10 indicated as beingconfigured for use across a vessel diameter of 2 mm to 3 mm, braidedimplant 10 was observed as providing approximately 70% porosity, whereasa comparable PED device was only able to maintain approximately 70%porosity across a vessel diameter of 2.5 mm to 2.75 mm (i.e. only a 0.25mm vessel diameter range). Another PED device in the relevant diameterrange was necessary for said PED device just to complete the gap from2.75 mm to 3.0 mm vessel diameter range, as shown. The first braidedimplant (10) was constructed from 48 strands of wire and the PED devicewas similarly constructed from 48 strands of wire. For the 2.0 mm to 2.5mm range, two more PED devices would also be required, since the PEDdevice only demonstrated a 0.25 mm range capable of maintaining 70%porosity during use.

FIG. 6 also depicts that a second braided implant (10) indicated asbeing configured for use across a vessel diameter of 2.5 mm to 3.5 mm,braided implant (10) was observed as providing approximately 70%porosity, whereas a comparable PED device was only able to maintainapproximately 70% porosity across a vessel diameter of 3.0 mm to 3.25 mm(i.e. only a 0.25 mm vessel diameter range). The second braided implant(10) in this example was constructed from 64 strands of wire while thePED device was constructed from 48 strands of wire. In other words, at avessel diameter of 3 mm, the second braided implant (10) usedapproximately 21.3 strands/mm of vessel diameter while the PED deviceused 16 strands/mm of vessel diameter. As a result of using fewerstrands per diameter, the PED device has a porosity vs diameter curvethat has a narrower plateau section than the second braided implant(10). Further, another PED device in the relevant diameter range wasnecessary for said PED device just to complete the gap from 3.25 mm to3.50 mm vessel diameter range, as shown. Further, as shown with respectto the 2.5 mm to 3.0 mm range and the first braided implant (10), twomore PED devices would also be required, since the PED device onlydemonstrated a 0.25 mm range capable of maintaining 70% porosity duringuse.

FIG. 6 also depicts that a third braided implant (10) indicated as beingconfigured for use across a vessel diameter of 3.0 mm to 4.0 mm, braidedimplant (10) was observed as providing approximately 70% porosity,whereas a comparable PED device was only able to maintain approximately70% porosity across a vessel diameter of 3.5 mm to 3.75 mm (i.e. only a0.25 mm vessel diameter range). The third braided implant (10) in thisexample was constructed from 64 strands of wire while the PED device wasconstructed from 48 strands of wire. In other words, at a vesseldiameter of 3.5 mm, the third braided implant (10) used approximately18.3 strands/mm of vessel diameter while the PED device used 13.7strands/mm of vessel diameter. As a result of using fewer strands perdiameter, the PED device has a porosity vs diameter curve that has anarrower plateau section than the third braided implant (10). Further,another PED device in the relevant diameter range was necessary for saidPED device just to complete the gap from 3.75 mm to 4.00 mm vesseldiameter range, as shown.

FIG. 6 also depicts that a fourth braided implant (10) indicated asbeing configured for use across a vessel diameter of 3.5 mm to 4.5 mm,braided implant (10) was observed as providing approximately 70%porosity, whereas a comparable PED device was only able to maintainapproximately 70% porosity across a vessel diameter of 4.0 mm to 4.25 mm(i.e. only a 0.25 mm vessel diameter range). The fourth braided implant(10) in this example was constructed from 72 strands of wire while thePED device was constructed from 48 strands of wire. In other words, at avessel diameter of 4 mm, the fourth braided implant (10) usedapproximately 18 strands/mm of vessel diameter while the PED device used12 strands/mm of vessel diameter. As a result of using fewer strands perdiameter, the PED device has a porosity vs diameter curve that has anarrower plateau section than the fourth braided implant (10). Further,another PED device in the relevant diameter range was necessary for saidPED device just to complete the gap from 4.25 mm to 4.50 mm vesseldiameter range, as shown.

FIG. 6 also depicts that a fifth braided implant (10) indicated as beingconfigured for use across a vessel diameter of 4.0 mm to 5.0 mm, braidedimplant (10) was observed as providing approximately 70% porosity,whereas a comparable PED device was only able to maintain approximately70% porosity across a vessel diameter of 4.5 mm to 4.75 mm (i.e. only a0.25 mm vessel diameter range). The fifth braided implant (10) in thisexample was constructed from 96 strands of wire while the PED device wasconstructed from 48 strands of wire. In other words, at a vesseldiameter of 4.5 mm, the fifth braided implant (10) used approximately21.3 strands/mm of vessel diameter while the PED device used 10.7strands/mm of vessel diameter. As a result of using fewer strands perdiameter, the PED device has a porosity vs diameter curve that has anarrower plateau section than the fifth braided implant (10). Further,another PED device in the relevant diameter range was necessary for saidPED device just to complete the gap from 4.75 mm to 5.00 mm vesseldiameter range, as shown.

FIG. 6 also depicts that a sixth braided implant (10) indicated as beingconfigured for use across a vessel diameter of 4.5 mm to 5.5 mm, braidedimplant (10) was observed as providing approximately 70% porosity,whereas a comparable PED device was only able to maintain approximately70% porosity across a vessel diameter of 5.0 mm to 5.25 mm (i.e. only a0.25 mm vessel diameter range). The sixth braided implant (10) in thisexample was constructed from 96 strands of wire while the PED device wasconstructed from 48 strands of wire. In other words, at a vesseldiameter of 5.0 mm, the sixth braided implant (10) used approximately19.2 strands/mm of vessel diameter while the PED device used 9.6strands/mm of vessel diameter. As a result of using fewer strands perdiameter, the PED device has a porosity vs diameter curve that has anarrower plateau section than the sixth braided implant (10). Further,another PED device in the relevant diameter range was necessary for saidPED device just to complete the gap from 5.25 mm to 5.50 mm vesseldiameter range, as shown.

As seen in FIG. 6, for each indicated 1 mm vessel range covered by oneof braided implants (10), four separate PED devices would be required bythe practitioner for similar coverage in corresponding vessels, which isboth inconvenient, wasteful, but quite possibly unsafe given the natureof blood vessels afflicted with hemorrhagic events and tendencies totaper considerably. For example, if a vessel were to taper more than0.25 mm, then no current PED device would adequately treat the afflictedvessel in a manner than maintains a substantially consistent targetporosity of 70%.

In FIG. 7, a flow diagram depicts one example method 700 andcorresponding steps. Step 710 includes determining a vessel diameterassociated with a vessel having the aneurysm. Step 720 includesselecting one of a plurality of braided implants (10) for treating thevessel, wherein each braided implant (10) comprises a porositysubstantially consistent over up to a 1 mm vessel diameter range, eachbraided implant (10) configured to provide substantially consistentporosity over different 1 mm diameter ranges. Step 730 includes treatingthe vessel with the one of the plurality of braided implants (10).

In FIG. 8, a flow diagram depicts one example method 800 andcorresponding steps. Step 810 includes determining a vessel diameterassociated with a vessel containing the aneurysm. Step 820 includesselecting one of a plurality of braided implants (10) for treating thevessel, wherein each braided implant (10) comprises a porositysubstantially consistent over at least a 0.5 mm vessel diameter range,each braided implant (10) configured to provide substantially consistentporosity over different 0.5 mm diameter ranges. Step 830 includestreating the vessel with the one of the plurality of braided implants(10).

The braided implants (10) of this disclosure are particularlyadvantageous since a doctor can benefit from a wider indicated diameterrange since it can afford some forgiveness for measurement inaccuraciesand/or errors (e.g. an artery is measured on X-ray or any othervisualization means to be 3.3 mm when it is actually 3.5 mm). Doctorscan also benefit since a wider indicate diameter range can maintainconsistent porosity close to the target porosity in tapering vessels,which is common. The implant (10) of this disclosure is alsoadvantageous since the anatomical range of artery diameters can betreated with fewer devices, simplifying the device selection process andsaving storage space for the inventory they must keep on hand.

In certain examples, a set or family of implants (10) is disclosed, eachwith a 1.0 mm wide indicated diameter range, are arranged such that theycover the anatomical range with 0.5 mm overlap, as shown in FIGS. 5-6.It is noted that the ranges depicted and described throughout referencea vessel diameter range of up to 1 mm for a respective braided implant(10). However, it is contemplated that the braided implant (10) can beadapted for more than a 1 mm vessel diameter range. The braided implants(10) of this disclosure are s particularly advantageous since for anygiven artery diameter, there exists two different options of a devicethat can be selected. For example, an artery with a diameter of 3.25 mmcan be at a desired treatment location in the vasculature. If the arterytapers down as you move away from the treatment location (i.e. becomessmaller), then the doctor could select the smaller implant from the setor family of implants by, for example, selecting an implant listed at2.5 mm, rather than 3.5 mm. In this respect, the artery segment isexposed to target porosity over a longer length. Conversely, if theartery tapers up as you move away from the treatment location (i.e.becomes larger), then the doctor could select the larger implant fromthe set or family by, for example, selecting an implant listed at 3.0 mmto 4.0 mm. In this respect, similar to the previous example, the arterysegment is exposed to the target porosity over a longer length.

The advantages in the present disclosure result from providing a braidedimplant with a broad plateau area of the characteristic porosity curveso that implant or the family or set of implants is capable of treatingartery diameters within the plateau of an approximate 1.0 mm wideindicated range, and overlapping the indicated diameter ranges so thedoctor has options for the best choice depending on the anatomypresented.

In certain examples, each of the side-by-side filaments of the braidedimplants of this disclosure include a monofilament of radiopaquematerial. In one construction, the carrier having the multi-strand issubstantially the same as the carriers for the single strands. Each ofthe side-by-side filaments of the multi-strand is a monofilament ofradiopaque material. Preferably, the diameter of each side-by-sidefilament is substantially the same as the diameter of the singlestrands. Forming the body includes establishing a first spacing pattern,such as an open braid pattern or an open weave pattern, and a first wallthickness, and each multi-strand joins in the first spacing patternwithout substantial deviation from that pattern and withoutsubstantially altering the first wall thickness.

In certain techniques, at least one multi-strand carrier is utilized forevery dozen single-strand carriers. Some machines have at least 42carriers, such as 48 carriers, and at least 6 of the carriers, such as 8carriers, are loaded with the multi-strands of radiopaque material. Thisstill results in a 48-carrier braid but having double the number ofradiopaque strands as when the 8 carriers are loaded with single strandsof radiopaque material.

Braided implants of this disclosure, including flow diverters, can bedesigned for a specific percentage of coverage area per artery area orinversely, the percentage of open area remaining per artery area, knownin this disclosure as “porosity”, after they have been delivered andexpanded in place at the treatment site. The designed porosity can beadjusted by the braiding parameters, such as number of wires, width ofwires, braided diameter, and braiding angle which can be alternativelymeasured as PPI or pitch. Once the target porosity is identified basedon these factors, the braid design can be adjusted so that it reachesthe target porosity when expanded to the indicated artery diameter.

Braided implants of this disclosure, including flow diverters, can havemany variants within a set or family that reach the target porosity atdifferent artery diameters. Therefore, the set or family of devicestogether allow the physician to treat any diameter artery within theanatomical range (1.5 mm to 6 mm is typical for neurovascular).

The descriptions contained herein are examples illustrating the variousembodiments and are not intended to limit the scope of the disclosure.As described herein, the invention contemplates many variations andmodifications of a system, device, or method that can be used.Variations can include but are not limited to alternative geometries ofelements and components described herein, utilizing any of numerousmaterials for each component or element (e.g. radiopaque materials,memory shape metals, etc.). These modifications would be apparent tothose having ordinary skill in the art to which this invention relatesand are intended to be within the scope of the claims which follow.

The specific configurations, choice of materials and the size and shapeof various elements can be varied according to particular designspecifications or constraints requiring a system or method constructedaccording to the principles of the disclosed technology. Such changesare intended to be embraced within the scope of the disclosedtechnology. The presently disclosed embodiments, therefore, areconsidered in all respects to be illustrative and not restrictive. Itwill therefore be apparent from the foregoing that while particularforms of the disclosure have been illustrated and described, variousmodifications can be made without departing from the spirit and scope ofthe disclosure and all changes that come within the meaning and range ofequivalents thereof are intended to be embraced therein.

What is claimed is:
 1. A method of treating an aneurysm, the methodcomprising: determining a diameter associated with a vessel having theaneurysm, the vessel being tapered up to a 1 mm diameter range;selecting one of a plurality of braided implants for treating thevessel, wherein each braided implant comprises a porosity of 65%-70%that is consistent over the up to a 1 mm diameter range, each braidedimplant configured to provide consistent porosity over different 1 mmdiameter ranges; and treating the vessel with the one of the pluralityof braided implants.
 2. The method of claim 1, wherein the taperedvessel comprises a proximal diameter and a distal diameter that differby up to 1 mm, wherein the determining the vessel diameter comprisescomparing the proximal and distal end diameters, the method furthercomprising: maintaining the consistent porosity across the taperedbraided implant.
 3. The method of claim 1, wherein the treating thevessel comprises: advancing the braided implant to an aneurysm; andreconstructing blood flow in the vessel by excluding the aneurysm anddiverting blood flow from the aneurysm using the selected one of theplurality of braided implants.
 4. The method of claim 1, the vessel istapered and the diameter of the vessel ranges between 3-4 mm.
 5. Themethod of claim 1, the vessel is tapered and the diameter of the vesselranges between 3.5-4.5 mm.
 6. The method of claim 1, the vessel istapered and the diameter of the vessel ranges between 4-5 mm.
 7. Themethod of claim 1, the vessel is tapered and the diameter of the vesselranges between 4.5-5.5 mm.
 8. The method of claim 1, the vessel istapered and the plurality of braided implants is configured to treatvessel diameters ranging between 1.5-6 mm.
 9. The method of claim 1, thestep of determining the diameter is implemented by X-ray, fluoroscopy,or MRI.
 10. The method of claim 1, wherein a predetermined lengthbetween proximal and distal ends of at least one of the braided implantsis at least 3 cm.
 11. The method of claim 1, wherein a predeterminedlength between proximal and distal ends of at least one of the braidedimplants is at least 1 cm.
 12. The method of claim 1, furthercomprising: providing, for each braided implant, an indicated diameterthat coincides with a peak of a porosity curve of the respective braidedimplant.
 13. The method of claim 12, further comprising: corresponding aporosity plateau to the 1 mm diameter range disposed about the peak ofthe porosity curve.
 14. The method of claim 1, wherein a pore density ofeach braided implant is 18 to 23 pores/mm².
 15. The method of claim 1,wherein at least one of the braided implants is a cylindrical porousstructure.
 16. The method of claim 1, further comprising: forming atleast one of the braided implants from a plurality of single strandscomposed of at least a first material and one or more radiopaquemulti-strands.
 17. The method of claim 1, further comprising: forming atleast one of the braided implants of monofilaments each laid togetherwith monofilaments, respectively.
 18. The method of claim 1, wherein the1 mm diameter range of each of the plurality of braided implantsoverlaps with the 1 mm diameter ranges of at least one other braidedimplant of the plurality of braided implants.
 19. The method of claim 1,wherein the 1 mm diameter range of each of the plurality of braidedimplants overlaps with the 1 mm diameter ranges of at least one otherbraided implant of the plurality of braided implants by 0.5 mm.
 20. Themethod of claim 16, wherein the strands of the multi-strands areparallel to each other.